BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2192021 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10279
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SLOW FLOW SUPPLY ALARM WITH AIR IN SUPPLY LINE WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT COULD NOT BE DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SLOW FLOW SUPPLY ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DWELL 1. THE CAREGIVER (CG) STATED THAT THE SUPPLY BAG WAS FULL AND THEY JUST HAD A LOT OF BUBBLES IN THE SUPPLY LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CG CHECK THE SUPPLY LINE AND CONDUCTED TROUBLESHOOTING STEPS WITH THE CG AND THE HEATER BAG BEGAN REFILLING. THE ALARM DID NOT REPEAT. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) ON (B)(6) 2011, REGARDING THE REPORTED SLOW FLOW SUPPLY ALARM. THE RN STATED SHE HAD NOT BEEN MADE AWARE OF THE ALARM; CAREGIVERS ARE TOLD TO CALL BAXTER'S TECHNICAL SERVICE CENTER IF IT IS A TECHNICAL ISSUE AND IF THE PROBLEM IS NOT RESOLVED THEN THEY ARE TOLD TO CALL THE NURSE. THE RN STATED AS FAR AS SHE KNEW THE PATIENT WAS CONTINUING THERAPY ON THE CYCLER SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR HOMECHOICE PRO